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Because lipid-insoluble quaternary cations pass into breast milkcaution should be exercised when COMBIVENT Inhalation Aerosol is administered to a nursing mother.

Albuterol has been shown in most clinical trials to have more bronchial smooth muscle relaxation effect than isoproterenol at comparable doses while producing fewer cardiovascular effectsHoweverall beta-adrenergic drugsincluding albuterol sulfatecan produce a significant cardiovascular effect in some patientssee PRECAUTIONS

Patients should be cautioned to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow-angle glaucomamydriasisincreased intraocular pressureacute eye pain or discomforttemporary blurring of visionvisual halos or colored images in association with red eyes from conjunctival and corneal congestionPatients should also be advised that should any combination of these symptoms developthey should consult their physician immediately.

NoteThe indented statement below is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbonsCFCs

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the three primary efficacy comparisons were i non-inferiority of combivent respimat 20 100 mcg to cfc-propelled combivent inhalation aerosol 36 206 mcg for the fev 1 auc0-6h on test day 85; ii superiority of combivent respimat 20 100 mcg to ipratropium respimat 20 mcg for the fev 1 auc0-4h on test day 85, to demonstrate the contribution of albuterol in the combination product, and iii non-inferiority of combivent respimat 20 100 mcg in comparison to ipratropium respimat 20 mcg for fev 1 auc4-6h on test day 85, to demonstrate the contribution of ipratropium in the combination product.